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Target enrollment of 100 patients with high-risk, BCG-unresponsive NMIBC with CIS achieved
enGene plans to provide an update from LEGEND's pivotal cohort in 4Q 2025
Biologic License Application (BLA) submission planned for 2H 2026
enGene Holdings Inc. (NASDAQ:ENGN, "enGene" or the "Company"))), a clinical-stage, non-viral gene therapy company, today announced it has achieved its target enrollment milestone of 100 patients for the pivotal cohort of its ongoing, open-label, multi-cohort Phase 2 LEGEND trial of detalimogene voraplasmid ("detalimogene" and previously EG-70) in patients with high-risk, non-muscle invasive bladder cancer (NMIBC). LEGEND's pivotal Cohort 1 is studying detalimogene in patients with high-risk NMIBC with carcinoma in-situ (CIS) with or without concomitant papillary disease. Patients in the screening process remain eligible for potential enrollment in the trial. The Company expects to overenroll in its pivotal cohort resulting in an adjustment in guidance for a BLA submission to 2H 2026.
Posted In: ENGN
